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Quality Technician - Caps

Company

B. Braun Medical Inc.
Address , Phoenix, 85043, Az
Employment type FULL_TIME
Salary
Expires 2023-07-24
Posted at 11 months ago
Job Description
Overview:
CAPS®, the nation's largest network of outsourcing admixture pharmacies, has been delivering high-quality, same-day, admixture services and solutions to hospitals and outpatient facilities for more than 28 years. Along with the nation’s largest 503A sterile injectable outsourcing network, CAPS offers industry-leading batch compounding on a national scale through three 503B registered outsourcing facilities. With experience, capacity, and a passion for safety, CAPS is your 503B solution.
CAPS is part of the B. Braun Group of Companies in the U.S.

Responsibilities:
Position Summary:

Ensure and assist with site-specific quality compliance according to CAPS Standard Operating Procedures (SOPs) & specifications, quality review of documents, label control, assist with release activities and product inspections.

Essential Duties/Responsibilities:
  • Verify and account for labeling
  • Maintain quality records (equipment calibration and maintenance, training, deviation and complaint investigation, environmental monitoring, Certificate of Analysis, clean room certification etc.).
  • Verify that all documentation is complete
  • Assist with equipment calibration program and maintenance record files.
  • Verify that product test results meet specification limits
  • Perform document review of compounding activities such as cleaning records, line clearance forms and inventory sheets:
    • Verify that raw materials meet specification
    • Verify and account for labeling
    • Review temperature and BMS alarms
    • Verify that product test results meet specification limits
    • Verify that all documentation is complete
    • Document non-compliance and work with supervisor/lead if further investigation is needed
  • Perform product inspection for defects, leaks and particulates.
  • Verify that raw materials meet specification
  • Under the direction of supervisor/lead, document and initiate quality events for deviation and complaint investigations.
  • Support internal & external audits.
  • Perform environmental monitoring of personnel (as needed) and complete documentation.
  • Participate in Quality Manager’s staff meetings
  • Document non-compliance and work with supervisor/lead if further investigation is needed
  • Submit samples to the appropriate lab for particulate identification or microbial analysis.
  • Assist in the media fill process validations to include inspection of filled units
  • Review temperature and BMS alarms
  • Assist with raw material release and movement.
Expertise: Knowledge & Skills
  • Ability to work within established procedures and practices
  • Knowledge of pharmacy operations and regulatory guidelines.
  • Ability to perform calculations.
  • Ability to effectively troubleshoot issues.
  • Strong organizational skills and attention to detail
Target Based Range: 19.22 - 24.03 Qualifications:
Qualifications - Experience/Training/Education/Certification/Etc:

Required:
  • Minimum of High School Diploma/GED with work experience
  • Minimum of 2 years experience in a quality or manufacturing department of a pharmaceutical, Medical Device or Allied Health Science.
Desired:
  • Associates Degree or higher level degree in Technician technical scientific discipline, Biology, Microbiology, Chemistry or Pharmacy.
  • Experienced in aseptic operations.
  • Experience within a regulated environment
While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to handle or feel and reach with hands and arms. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 45 pounds.

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Additional Information:
Responsibilities: Other Duties:

The preceding functions have been provided as examples of the types of work performed by employees assigned to this position. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed in this description are representative of the knowledge, skill, and/or ability required. Management reserves the right to add, modify, change or rescind the work assignments of different positions due to reasonable accommodation or other reasons.

Physical Demands:
  • The employee must occasionally lift and/or move up to 45 pounds.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Work Environment:
  • Indoors, cleanroom, working environment limited to a small area, wearing protective cleanroom attire, tolerating controlled temperatures and loud noise.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually moderate.
What We Offer : B. Braun offers an excellent benefits package, which includes healthcare, a 401(k) plan, and tuition reimbursement. To learn more about B. Braun and our safety healthcare products or view a listing of our employment opportunities, please visit us on the internet at www.bbraunusa.com. Through its “Sharing Expertise®” initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services. Notices:
Equal Opportunity Employer Veterans/Disabled